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NCT05777031 · ClinicalTrials.gov registry record · Phase 4
Safety and Efficacy of Collagenase Clostridium Histolyticum After Prior Intralesional PRP for Peyronie's Disease
A Phase 4 study of Genital Diseases, Male and Peyronie Disease, sponsored by University of Miami.
- Recruiting
- Registry status
- Phase 4
- Development phase
- 22
- Enrollment target
- 2
- Study locations
NCT05777031: Recruiting Phase 4 study of Genital Diseases, Male and Peyronie Disease, sponsored by University of Miami.
NCT05777031 is a Phase 4 study of Genital Diseases, Male and Peyronie Disease that is actively recruiting participants, run by University of Miami. The registered enrollment target is 22 participants, below the 70-participant average among 4 other Genital Diseases, Male trials with a reported enrollment target (69% lower). The trial reports 2 study locations across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05777031, a Phase 4 study of Genital Diseases, Male and Peyronie Disease, is actively recruiting participants, sponsored by University of Miami.
- RECRUITING
- Registry status
- Phase 4
- Development phase
- 22 participants
- Enrollment target
- 2
- Study locations
Study Summary
The purpose of this study is to learn about the safety and side effects of intralesional collagenase clostridium histolyticum (CCH) injected into the Peyronies Disease (PD) plaque after receiving prior treatment with intralesional Platelet Rich Plasma (PRP) injections.
Primary Outcome
To determine number of treatment related adverse events. Safety will be evaluated via the incidence of adverse events as assessed by treating physician
Conditions Studied
Interventions
- DRUG Collagenase Clostridium Histolyticum (CCH)
Study Locations (2)
Florida
- University of Miami - Desai Sethi Urology Institute - Miami
- University of Miami - Miami
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 22 participants |
| Start Date | 2023-10-02 |
| Est. Completion | 2027-01-15 |
| Phase | Phase 4 |
What NCT05777031 shows while recruiting
NCT05777031 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 22 participants, a relatively small participant target, below the 70-participant average among 4 other Genital Diseases, Male trials with a reported enrollment target (69% lower).
The record links to 3 conditions, with Genital Diseases, Male appearing as the primary indexed condition, and to 1 intervention - of which Collagenase Clostridium Histolyticum (CCH) is the first listed.
NCT05777031 reports a single indexed study location in Florida.
Frequently Asked Questions
What is clinical trial NCT05777031 about?
NCT05777031 is a clinical study titled "Safety and Efficacy of Collagenase Clostridium Histolyticum After Prior Intralesional PRP for Peyronie's Disease". The purpose of this study is to learn about the safety and side effects of intralesional collagenase clostridium histolyticum (CCH) injected into the Peyronies Disease (PD) plaque after receiving prior treatment with intralesional Platelet Rich Plasma (PRP) injections.
What is the current status of trial NCT05777031?
This trial is currently recruiting. It is a Phase 4 study. The enrollment target is 22 participants. The study started on 2023-10-02. Estimated completion is 2027-01-15.
What conditions does trial NCT05777031 study?
This clinical trial studies the following conditions: Genital Diseases, Male, Peyronie Disease, Sexual Dysfunctions, Psychological.
What interventions are being tested in trial NCT05777031?
The interventions under investigation include: Collagenase Clostridium Histolyticum (CCH) (DRUG).
Who is sponsoring clinical trial NCT05777031?
This trial is sponsored by University of Miami, which has 721 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05777031 being conducted?
This trial has 2 study locations across Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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